Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures

NCT ID: NCT00558246

Last Updated: 2012-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2009-10-31

Brief Summary

This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures. Breast procedures where symmetrical incisions of at least 15cm in length are planned for both breast (bilateral procedure) will be randomised to receive final skin closure of one breast with Prineo (DERMABOND PROTAPE) and the other with intradermal sutures (control). Patients will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).

Conditions

Macromastia

Keywords

Breast Lift; Breast Reduction; Breast Reconstruction; Plastic Surgery; Skin Closure; Wound Healing; Dermabond

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I

On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.

Group Type: EXPERIMENTAL

Dermabond Protape (Prineo)

Intervention Type: DEVICE

cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive

II

On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.

Group Type: ACTIVE_COMPARATOR

Suture

Intervention Type: DEVICE

Topical Suturing

Interventions

Dermabond Protape (Prineo)

cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive

Intervention Type: DEVICE

Suture

Topical Suturing

Intervention Type: DEVICE

Other Intervention Names

Prineo; Investigator selected the intradermal suture per standard local practice.

Eligibility Criteria

Inclusion Criteria

• Be at least 18 years of age;
• Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
• Require identical skin closure of full-thickness intersecting surgical incisions with a combined length of at least 15cm on each breast as part of elective breast procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;
• Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub until suture removal occurs (during the first 12-25 days) of the study;
• Agree to return for all follow-up evaluations specified in this protocol [7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)], six (± 1 month) and twelve months (± 1 month)];
• Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and
• Sign the informed consent.

Exclusion Criteria

• Have peripheral vascular disease;
• Have insulin dependent diabetes mellitus;
• Be known to have a blood clotting disorder;
• Be receiving antibiotic therapy for pre-existing condition or infection;
• Be known to be HIV-positive or otherwise immunocompromised;
• Have known personal or family history of keloid formation or hypertrophy;
• Be currently taking systemic steroids;
• Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
• Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and
• Be participating in any current clinical trial of an investigational product or have participated in any clinical trial of an investigational product within 30 days of enrolment in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Colquhoun, MD

Role: STUDY_DIRECTOR

Pleiad Devices

Locations

UZ

Ghent, , Belgium

Dreifaltigkeits-Krankenhaus

Cologne, , Germany

Markus Krankenhaus

Frankfurt, , Germany

Akademikliniken

Stockholm, , Sweden

Mid Essex Hospital

Broomfield, Essex, United Kingdom

Countries

Belgium; Germany; Sweden; United Kingdom

Other Identifiers

07CS003

Identifier Type: -

Identifier Source: org_study_id